Roche receives FDA approval for molecular test to screen blood donors for malaria

Roche announced the U.S. Food and Drug Administration approval of the cobas Malaria test for use on the cobas 6800/8800 Systems. This approved test can aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The cobas Malaria test provides a highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply. The cobas Malaria molecular test screens whole blood samples for the five main species of Plasmodium parasites that are known to cause human infection. The potential value of a molecular donor screening test for malaria is to improve both blood safety and availability. The test is intended for use in screening blood, organ and tissue donors. The test will be available in the United States at the end of Q2 2024. Approval in CE-marked countries is anticipated later this year.